| Journal: | Brazilian Journal of Pharmaceutical Sciences |
| Database: | PERIÓDICA |
| System number: | 000451978 |
| ISSN: | 1984-8250 |
| Authors: | Chagas, Stephanye Carolyne Christino1 Pimenta, Camila de Almeida Perez1 Kishishita, Juliana1 Barbosa, Irla Carla França1 Bedor, Danilo Cesar Galindo1 Aquino, Katia Aparecida da Silva2 Santana, Davi Pereira de1 Leal, Leila Bastos1 |
| Institutions: | 1Universidade Federal de Pernambuco, Departamento de Ciencias Farmaceuticas, Recife, Pernambuco. Brasil 2Universidade Federal de Pernambuco, Departamento de Energia Nuclear, Recife, Pernambuco. Brasil |
| Year: | 2022 |
| Volumen: | 58 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Experimental, aplicado |
| English abstract | Bioequivalence (BE) assessment of topical drug products is a long-standing challenge. Agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published several drafts in recent years suggesting different approaches as alternative to evaluate the BE. A proposed Topical Classification System (TCS) has even been discussed. Given the above, the objective of this research was to use in vitro and in vivo BE approaches to evaluate Brazilian marketed mupirocin (MPC) ointments, previously classified as TCS class The in vitro permeation test (IVPT) was performed by applying formulations to pig skin by Franz cells. The in vivo methodology was dermatopharmacokinetic (DPK). These approaches (in vivo tape stripping and IVPT) demonstrated capability of distinguishing among different formulations, thus making them useful methodologies for BE evaluation |
| Disciplines: | Medicina, Química |
| Keyword: | Dermatología, Farmacología, Medicación tópica, Bioequivalencia, Mupirocina |
| Keyword: | Dermatology, Pharmacology, Topical medication, Mupirocin, Bioequivalence |
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